KEY FEATURES AND MODULES
Manufacturing, QA & QC
Every manufacturing unit goes in hand with QA & QC industries in terms of aiming at their global objective. The primary motto tries to fetch a healthy competition with an enhancement in terms of quality and quantity production which has an on time delivery in the market accomplished with good coordination for execution of services.
To achieve such global challenges, maintaining the high quality requires an informatics solution. This proposition helps the various stake holders, to processes an effective and efficient method to collect, store, share, analyze and report the mounting data. In recent times, both government and private regulations have enforced the need of such informatics and data management systems as mandatory in manufacturing and QA&QC lab processes.
Ocimum’s QA&QC LIMS is designed to address the growing industry needs, with built-in capabilities that provide as much standard industry specific functionality as possible being “Commercially-Off-The-Shelf” (COTS) solution with high configurable options, designed exclusive for Pharmaceutical, chemical, water, environmental and biological manufacturing and QA&QC labs.
Why Ocimum’s QA&QC LIMS
- Streamline Quality Management, compliance and audit process
- Minimize transcription errors and achieve real time tracking
- Interoperability with supplier, store, QA&QC labs, production, and packaging departments
- Move from paper-based system by automating all the laboratory processes
- Support FDA (21 CFR Part 11), USDA3, EPA, HACCP, GLP and GMP compliance
- Enhanced lab control, future prediction and decision making ability
- Specification management – Enforce Standard Operating Procedures and business rules,
Create specifications (Specs) to samples, QC& QA validation of results, Accept or reject samples, Specifications history document
- Workflow Creation – Define QC tests- Inputs, Outputs, Execution Parameters and Thresholds, Define threshold for test result, Receive E-mail notification of changes to the workflow
- Workflow Execution – Recurring event Management, Single or batch Testing, Result Validation (QC approval/ Rejection), E-mail alerts and validations for results, Scheduling events in a Workflow, Manual Results Entry, Multiple Runs and re-runs, Test Analysis and reports
- OOS Management –
Alert Out-of-Specification via Email and system validations
Support OOS cycle, Manage Corrective action and preventive action (CAPA), Cohesive OOS report
- Trend Analysis –
Generate trend for a given period, Depicted in list and graphical form
- Compliance Regulatory compliance –
Quality Management System, USDA3, EPA, HACCP, GMP GLP and GALP, ISO, Audit Trails – 21CFRPart 11, Configure Electronic Signature validation.
- Material/Sample Management – Sample accessioning includes Sample meta data, Batch import, Barcodes, Assigning task and Sample tracking – Location management, genealogy, Chain of custody, Usage history, Aliquots and Pooling.
- Specification Management – Enforce Standard Operating Procedures and business rules, Create specifications (Specs) to samples, QC& QA validation of results, Accept or reject samples, Specifications history document.
- Instrument Management – Instrument demographic information, Track and schedule calibrations, Tracking maintenance history, Track vendor service contracts, Tracking validation history, Location history, User logs of instruments, User manuals and operation manuals
- Reports – Standard Reports and custom reports. Reports are generated in .pdf, word and XML formats
- Personnel Management, Role Management, Customer Vendor management, User logs
- Utilities – Dashboards, Modular, Customizable Fields and Interface, Email integration
- Web based, browser-independent solution
- Works on tablet PCs and Smart phones
- Offered as “On premise” solution and “SaaS” model
- API’s for easy, faster and secured data exchange with third party software and instruments
- Database Independent
- Pharmaceutical products and API
- Chemicals and Process manufacturing
- Water testing
- Environmental samples testing
- Minerals and Materials testing
- Biological agents manufacturing